Completed

NCT Number: NCT00965679

X-ray Fluoroscopy Fused With Computed Tomography (XFC) Technical Development

Background:

* Computed tomography (CT) creates three-dimensional images based on X-ray imaging. CT is useful for determining treatment approaches for certain diseases, such as calcific aortic stenosis (narrowing of the aorta because of calcium deposits). * Comparing the data received from CT scans with the data received from heart catheterization (which assesses the heart's condition and function) can be used to improve treatment in patients with certain heart conditions. Researchers are interested in looking at the effectiveness of both procedures in assessing possible surgical treatments for patients with calcific aortic stenosis.

Objectives:

- To analyze cardiac CT scans in conjunction with existing heart scan results to improve treatments for future minimally invasive aortic valve replacement.

Eligibility:

- Patients 18 years of age and older who have been diagnosed with aortic valve stenosis that may be treated surgically, and who will undergo or have recently undergone heart catheterization.

Design:

* Participants will have a CT scan within 90 days of the medically necessary heart catheterization, but before any other surgical or catheter treatment. * During the CT scan, patients will be asked to hold their breath intermittently for about 5 to 20 seconds. Patients will be inside the scanner for less than 30 minutes. * Patients will be asked to return in 3 to 7 days for a blood test to check kidney function. * Researchers will analyze the results of the CT scan in conjunction with the previous results from the catheterization to determine possible improved treatment options.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

About this study

We will collect cardiac computed tomography (CT) data from patients with aortic valve stenosis being considered for surgical or catheter treatment. These data will be analyzed along with medically-necessary fluoroscopy from cardiac catheterization to learn whether they can be combined to enhance future minimally invasive valve treatments.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

INCLUSION CRITERIA:

SELECTION CRITERIA: PATHWAY FOR RESEARCH CT:

Adult patients age 18 years or older
Having calcific aortic stenosis being considered for surgical or catheter-based treatment, determined on physical examination or noninvasive imaging such as echocardiography
Undergoing diagnostic cardiac catheterization within 1 year
Able to provide informed consent

ALTERNATIVE SELECTION CRITERIA: PATHWAY FOR ANALYSIS OF MEDICAL DATA:

Adult patients age 18 years or older
Having calcific aortic stenosis being considered for surgical or catheter-based treatment, determined on physical examination or noninvasive imaging such as echocardiography
Undergoing diagnostic cardiac catheterization within 1 year
Having undergone cardiac CT for medical indications meeting the technical requirements of this protocol
Able to provide informed consent

Exclusion criteria

SELECTION CRITERIA: PATHWAY FOR RESEARCH CT:

Pregnant or lactating women
Decompensated heart failure (unable to lie flat during CT)

Exclusion criteria

FOR BETA ADRENERGIC BLOCKERS:

Advanced atrioventricular block (Mobitz Type II second degree or third degree atrioventricular heart block)
Asthma or chronic obstructive pulmonary disease (emphysema) currently treated with beta adrenergic agonists

Exclusion criteria

FOR IODINATED RADIOCONTRAST:

-Severe kidney disease (MDRD estimated Glomerular Filtration Rate

< 30mL/min/l.73m(2)).

-Request of referring physician or surgeon not to administer iodinated radiocontrast

ALTERNATIVE SELECTION CRITERIA: PATHWAY FOR ANALYSIS OF MEDICAL DATA:

-None

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Registry information

Important dates

Study start: 2009
Study completion: 2010
First posted: Aug 25, 2009
Registry last updated: Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed